SGLT2 inhibitor approved by FDA in children ≥10 years for treatment of T2DMNews - June 27, 2023
The U.S. Food and Drug Administration (FDA) has approved the SGLT2 inhibitor empagliflozin 10 and 25 mg tablets to lower glucose levels in addition to diet and exercise in children 10 years and older with T2M.
This approval is based on results from the DINAMO phase III trial. In the DINAMO trial, use of empagliflozin reduced the primary endpoint of change in HbA1c by 0.8% (95%CI: -1.5 to -0.2, P=0.0116) at 26 weeks compared to placebo in patients 10-17 years with T2DM.
The safety profile in these pediatric patients treated with empagliflozin was similar to that observed in adult patients with T2DM, except that the risk of hypoglycemia was higher in pediatric patients.